Warning Letter – Solvay Pharmaceuticals

Solvay Pharmaceuticals 6/23/99 Computer System Validation

1. The xxxx computer system, used to monitor and maintain such critical systems as the xxxx and xxxx systems, has not been validated.

Our inspection revealed that the xxxx computer system is used to monitor temperature, conductivity, water pressure and time (in hours) for replacement of xxxx for the System. Additionally, this system monitors the differential pressure between the aseptic core and surrounding areas. The xxxx System, which has been in place since January 1998, has not been validated.

Your 4/12/99 written response to the FDA 483 indicates that the xxxx System will be validated according to the Validation Master Plan for 1999. However, this response is deficient in that it does not detail your plans for monitoring the parameters of the system and xxxx system while the xxxx computer system is being validated. You must assure that these parameters are monitored by reliable methods. Please provide us with a copy of the validation protocol.

2. The unit, used to compare the computer line’s air pressure measurement readings with equipment air pressure measurements, has not been calibrated. Additionally, there has been no periodic maintenance to assure that the unit is operating appropriately.

This issue becomes even more critical due to the fact that the xxxx computer system is not validated. It is essential that this unit, used to compare the readings of the computer with the air pressure monitoring equipment, be accurate and reliable.
Additionally, data (from this testing) was entered into the Laboratory Information Management System (LIMS) prior to the documented review of the data. This is a concern to us especially because our investigators observed the Responsible Pharmacist releasing product based only on the computer data. Therefore, it is conceivable that product is released to the market prior to a second review of raw data.

SoftwareCPR Keywords: software validation, drugs, pharmaceuticals

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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